Regulatory Affairs Manager Regulatory Affairs Manager - Medical Device - FDA

Skills Required - Regulatory Affairs, Medical Device/IVD/Pharma/Healthcare, IDE, PMA, MDR, 510K

Regulatory Affairs Manager

If you are a Regulatory Affairs Manager with experience, please read on!

Our client is a dynamic medical device company experiencing tremendous growth. We are looking for an experienced Regulatory Affairs Manager to provide regulatory support and assist with various ongoing projects in order to remain in with all FDA and other U.S. and international regulatory requirements.

What you need for this position:

- Regulatory Affairs experience in medical devices, IVD, pharmaceutical or other healthcare industry
- Experience with MDRs, IDEs, PMAs and 510k filings
- Interventional cardiology is a plus

What you'll be doing:

- Prepare regulatory filings such as IDE, PAM and Design Dossier submissions
- Attend Project Team Meetings
- Coordinate regulatory submissions
- Assist with preparation of presentations to FDA reviewers and/or inspections as needed
- Review and approve Product Incident and MDR reports
- Review and approve Engineering Change Orders, CAPAs, NCRs, etc.
- Ensure compliance with FDA and European regulations and guidelines as well as relevant company SOPs and protocols
- Prepare internation product registrations and licensing documentation
- Maintain information in various compliance databases and produce reports as needed

What's in it for you:

- Competitive Pay
- Outstanding benefits
- Join a company that is experiencing tremendous growth
- Excellent career opportunities
- Great work environment

So, if you are a Regulatory Affairs Manager with experience, please apply today!